ISO 13485 certification in Brazil - PowerPoint PPT Presentation

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ISO 13485 certification in Brazil

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ISO 13485 certification establishes the quality of medical devices and equipment. It ensures the high-level performance of the organizations Quality Management System. – PowerPoint PPT presentation

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Title: ISO 13485 certification in Brazil


1
ISO 13485 certification in Brazil
2
ISO 13485 standard what is it?
  • ISO 13485 certification establishes the quality
    of medical devices and equipment. It ensures the
    high-level performance of the organizations
    Quality Management System. This certification
    inspires manufacturers/suppliers to
    develop/produce safe, high quality products. This
    is also one of the globally accepted management
    system certifications. Therefore, it promotes
    your business and provides global recognition to
    the organization
  • While ISO 13485 and ISO 9001 are Quality
    Management System standards, ISO 13485 includes
    specific requirements to monitor, maintain,
    implement and improve the quality of medical
    devices and equipment. This standard provides
    effective measures to identify risks in the
    process of manufacturing, installing and
    maintaining medical devices and also to reduce
    them. Having a similar connection with the ISO
    9001 standard, you can easily implement it in
    your organization.
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